Total 4 Full-time Senior Executive Project Manager job vacancies in Quality Assurance / Control category in Malaysia

Senior Control Systems Engineer / Project Controls Engineer Listed 05/4/24 Infrastructure Permanent / Full Time Brisbane Project Engineer – Control Systems EngineeringSalary - $130K - $160K We are currently on the hunt for a local Project Engineer Control Systems Engineering with solid project experience within the Mining, Oil & Gas, Heavy Industries or Manufacturing industries! Join a leader in operational technology and engineering services, dedicated to empowering clients through automation and digital solutions. You'll drive innovation, mentor engineers, and create technical breakthroughs for our clientele by managing projects from end to end. Responsibilities: Develop control systems tailored for multiple industry applications. Lead and manage both Project and a team of engineers. Manage brownfield projects and navigate change management processes. Translate customer needs into robust engineering designs. Excel in communication, both written and verbal. Ensure timely, budget-compliant project delivery within fixed price scenarios. Conduct site audits, prepare estimates, and craft proposals. Interpret technical documents like P&IDs…

Click here to view more detail / apply for Senior Control Systems Engineer / Project Controls Engineer

 

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

In this role you will be part of Quality Assurance activities for Capex project as part of the Global Quality Engineering team. Projects will be part of Lonza’s Biologics growth portfolio  in Lonza’s IBEX BioPark in Visp. We are looking for an experienced quality assurance colleagues with drive to ensure the projects are completed on-time with a compliance mindset to add to our high performing team.

Key responsibilities:

• Owning all quality related responsibilities for the CQV Lifecycle Program for new facilities, equipment and utilities related to the GMP manufacturing of biologics & APIs

• Support the development, review and release of qualification documents according to the Validation Master plan for process plants with specific expertise on documentation for clean utilities

• Support and approve quality risk analyses

• Release of the qualified process equipment and ensure equipment is assessed with appropriate change management

• Ensure all deviations are appropriately investigated and recorded

• Responsible to drive CAPA and effectiveness check items to completion and timely closing

• Actively supports the Quality culture as a role model

Key requirements:

• Bachelor, Master degree or PhD in chemistry, biotechnology, life science or related field

• Significant experience in the GMP regulated pharmaceutical industry; preferable in a QA role

• Strong background in cGMP regulations and expertise in the qualification of Clean Utilities

• Experienced in the interaction with health authorities (Swissmedic, FDA etc.)

• Excellent verbal, written and interpersonal communication skills in English

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Senior Quality Project Engineer

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.

Alcon is the global leader in eye care, dedicated to helping people see brilliantly. With our 70-plus-year heritage, we are the largest eye-care device company in the world – with complementary businesses in Surgical and Vision Care. Being a truly global company, we work in over 70 countries and serve patients in more than 140 countries.

We are currently recruiting for a Senior Quality Project Engineer to join our team here in Cork. You research process technologies and process control improvements for site implementation. They apply comprehensive and diverse knowledge of engineering principles and practices for Quality focused process controls improvements. They use specialist knowledge and leadership in leading the execution of these improvement activities. A typical day in this role will include;

• Utilize Quality Engineering principles and problem-solving skills to improve and maintain processes that are aligned with the overall Quality and Business vision while ensuring production build schedule attainment.
• Responsible for introducing and validating new process control projects from design through completion and in compliance with regulatory requirements.
• Work with automation solution providers to specify, design and implement solutions if necessary. Responsible for supporting and improving existing process controls through process analysis and the application of engineering principles.
• Employ appropriate risk management to prevent unanticipated failure modes.
• Ensures effective quality strategies are created for the validation of equipment, test methods and processes as well as risk management documentation in accordance with regulatory requirements and internal Alcon requirements.
• Responsible for project management & planning and for liaising with other departments/plants affected by these projects. Also for reporting project status to management and highlighting areas of concern early. Responsible for ensuring all projects are completed to agreed timelines and within budget. Also that all work adheres to H&S and environmental requirements.
• Author/Reviews Test Methods, Specifications, Validation Protocols, Deviations, Investigations, Impact Assessments and other forms of Quality documentation as assigned.
• Perform an active role in further development of the quality management system and drive continuous improvement and innovation from a quality perspective.
• Actively participate in external audits by Notified Bodies and Health Authorities as subject matter expert for areas of responsibility.

What You Will Bring To Alcon:

• Third level qualification in a Business or Engineering Discipline
• As minimum 5-10 years in a medical device or pharmaceutical environment
• Preferred 5 years’ experience in Medical Device or Pharmaceutical industry with a Bachelors degree in a technical discipline
• Knowledge of FDA, medical device, GMP and validation requirements.
• Experience in Equipment and process validations.
• Excellent Project management problem solving & analytical ability.
• Attention to detail with excellent organizational skills.
• Knowledge of Line Clearance and Product Segregation requirements Report writing expertise and highly developed people skills.                                      

How You Can Thrive At Alcon

• A competitive salary package with fixed salary, bonus, pension and health insurance
• A flexible work environment with competent and committed colleagues. We enjoy working together in a good and respectful manner, and we celebrate our common successes
• See your career like never before with focused growth and development opportunities                                 

Alcon Careers

See your impact at www.alcon.com/careers

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Key Responsibilities

- Participate in requirement analysis sessions and provide feedback on any deviation from QA standards, design defects, missing or ambiguous requirements
- Provide Test Schedules and Test estimates for different phases of testing on the Program
- Prepare Master Test Strategy and Master Test Plan for the Program
- Script and maintain Test Approach, end-user documentation, and operational procedures
- Guide the team to prepare Test scenarios and Test cases and liaison with business analysts, the development team, and business stakeholders to obtain sign-offs
- Map all Test cases to Functional Requirement Documents to achieve 100% requirement traceability
- Lead test execution cycles
- Provide Weekly Execution Status Report and Test Summary Report to all stakeholders
- Define Defect Management Process
- Chair daily Defect meetings with the leads of the Development, Test, and Business Analyst teams, and provide clear actions
- Create a knowledge transition plan for the offshore team, implement and measure effectiveness on regular intervals
- Interact with key Stakeholders on a regular basis to ensure program outcomes are met
- Support the project team in leveraging testing tools to improve team productivity and effectiveness (Test Management and Defect Management)
- Management and communication of risks and issues pertaining to vendors and associated dependencies

We are looking for:

- Bachelor’s degree in computer science or related field
- 10+ years’ experience in technology or business analysis positions, or experience in the Quality Assurance field
- Hands-on experience in Agile/Scrum Methodology and JIRA system is preferred
- Analytical skills with the ability to think logically and in a structured approach
- Strong prior manual and Automation testing experience
- Strong stakeholder management experience
- Excellent communication required (verbal, written, reporting), with good presentation skills
- A self-starter who is user-focused, detail-oriented, and an enthusiastic team player